Lumbar Spinal Stenosis (LSS) is one of the most common reasons for spine surgery in older people. Spinal stenosis is a medical condition in which the spinal canal narrows and compresses the spinal cord and nerves. This is usually due to the natural process of spinal degeneration that occurs with aging. It may also be caused by spinal disc herniation, osteoporosis, or a tumor. Spinal stenosis may affect the cervical or lumbar vertebrae or both. Lumbar spinal stenosis results in lower back pain as well as pain or abnormal sensations in the legs, thighs, feet or buttocks, or loss of bladder and bowel control.
Laminectomy is a basic part of the surgical treatment of LSS and is an effective remedy for severe spinal stenosis. Laminectomy can be done without spinal fusion; however, if the spinal column is unstable, fusion may be required for the laminectomy.
Lumbar interspinous process decompression (“IPD”), also known as interspinous distraction or posterior spinal distraction, has been proposed as a minimally invasive alternative to laminectomy and fusion. In IPD, an interspinous distraction implant, also called a spacer, is inserted between the spinous processes through a small (4-8 cm) incision. The supraspinous ligament is maintained and assists in holding the implant in place, such that no laminotomy, laminectomy, or foraminotomy is performed. The device is intended to restrict painful motion while enabling otherwise normal motion. The device theoretically enlarges the neural foramen, decompresses the cauda equina, and acts as a spacer between the spinous processes to maintain the flexion of the spinal interspace.
Therefore, a device that can be implanted between two spinous processes of the spine more easily and which involves less invasive procedures than present day procedures is needed. Also, a device which can easily be adapted for both fusion and non-fusion procedures is needed. Such a device would aid in the treatment for spinal stenosis. Current prior art devices are made of multiple parts, are bulky, and require complex delivery instrumentations to position, assemble and deploy a clamping apparatus. The present invention attempts to solve these problems, as well as others.